FDA 483 - Sciegen Pharmaceuticals Inc - December 20, 2021

Sciegen Pharmaceuticals Inc. in Hauppauge, NY, was cited for failing to store drug products under appropriate temperature conditions during an FDA inspection. The firm's temperature mapping studies for two warehouses, which store finished drug products and APIs, were found to be deficient. Issues included a failure to record outside temperatures during studies and missing data, raising concerns about product identity, strength, quality, and purity.